Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults
Study Details
Study Description
Brief Summary
Cough is a defensive behavior that involves three stages. A large inspiratory phase, a compression phase where the vocal folds close and subglottal pressure is developed, and an expiratory phase. Cough serves to protect the upper and lower airways from material such as liquids, solids, or saliva, that have been aspirated. There are two types of cough: voluntary and reflex cough. Voluntary cough involves a cough to command. Reflex cough is a cough that is generated secondary to a stimulus in or near the airway. There has been some research regarding the differences between voluntary and reflex cough. However, no research has described the differences in airflow or movement pattern (kinematics) between the two types of cough. This study seeks to determine the respiratory kinematics and airflow differences between voluntary and reflex cough in healthy participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
As a participant, completion of this study will require the following:
Investigators will first place cotton elastic bands around your chest and abdomen so that measures of chest wall and abdominal movements can be measured. Then, tests of your breathing made from pulmonary function testing will be completed.
Investigators will then have you complete a maximum inspiration followed by a maximum expiration three times.
Investigators will ask you to produce a voluntary cough three times into a facemask which is attached to a computer.
Then the investigators will provide you with nebulized water (FOG) through the facemask for up to a minute three times. You will have a minute break in between each presentation.
Finally, the investigators will provide you with a nebulized dose of Capsaicin, which is derived from hot peppers, through the same facemask used in all of the above tasks. You will receive three doses of capsaicin and be provided with water at any time during the study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Healthy adults who receive capsaicin Single treatment consisting of healthy adults. |
Drug: Healthy adults who receive capsaicin
Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Lung Volume Initiation [1 hour]
Respiratory kinematic measure: lung volume initiation (LVI) Lung volume initiation is a measure of the volume of air in the lungs prior to a respiratory task.
Secondary Outcome Measures
- Peak Expiratory Airflow Rate [1 hour]
Airflow measures: Peak expiratory airflow rate Peak expiratory flow rate is a measure of the velocity of air expelled from the respiratory apparatus during cough. Measured in liters/second.
- Urge-to-cough [1 hour]
Urge-to-cough: A measure of respiratory sensation that rates the perceived magnitude of the need to cough on a Borg scale (0=no urge-to-cough; 10=maximal urge-to-cough).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy adults between the ages of 18-80 years.
-
Ability to provide informed consent.
Exclusion Criteria:
-
No history of smoking within the last 5 years as this reduces the sensitivity to capsaicin
-
No history of neurological disease (i.e. Parkinson's disease, stroke, traumatic brain injury, etc.)
-
No known allergy to capsaicin
-
No history of respiratory disease (i.e. asthma, chronic obstructive pulmonary disease, or respiratory infection within the last 5 weeks.)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Florida, Dauer Hall | Gainesville | Florida | United States | 32611 |
Sponsors and Collaborators
- University of Florida
Investigators
- Principal Investigator: Alexandra E. Brandimore, M.A., University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 32-2013
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Healthy Adults Who Receive Capsaicin |
|---|---|
| Arm/Group Description | Single treatment consisting of healthy adults. Healthy adults received capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in the chest wall and abdomen during cough. Participants breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. Participants received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants rested for a minute in between each presentation and water was available at all times. Pulmonary function testing: Investigators placed cotton elastic bands around the chest and abdomen so that measures of chest wall and abdominal movements could be measured. Forced vital capacity and rest breathing was completed. Nebulized water (Fog): The investigators provided nebulized water (FOG) through the facemask for up to a minute three times. A minute break was allotted between each presentation. |
| Period Title: Overall Study | |
| STARTED | 25 |
| COMPLETED | 25 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Healthy Adults Who Receive Capsaicin |
|---|---|
| Arm/Group Description | Single treatment consisting of healthy adults. Healthy adults who receive capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. The participant received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants had a minute in between each presentation and water was available at all times. Pulmonary function testing: Investigators will first place cotton elastic bands around your chest and abdomen so that measures of chest wall and abdominal movements can be measured. Forced vital capacity and rest breathing maneuvers were completed. Nebulized water (Fog): The investigators will provide you with nebulized water (FOG) through the facemask for up to a minute three times. A minute break in between each presentation. |
| Overall Participants | 25 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
25
100%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
23.3
(3.3)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
14
56%
|
| Male |
11
44%
|
| Region of Enrollment (participants) [Number] | |
| United States |
25
100%
|
| Lung volume initiation (%vital capacity, relative to EEL) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [%vital capacity, relative to EEL] |
23.3
(5.8)
|
| Peak expiratory airflow rate (Liters/second) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Liters/second] |
6.058
(.56)
|
| Urge-to-cough (units on a scale) [Median (Standard Deviation) ] | |
| Median (Standard Deviation) [units on a scale] |
7
(.32)
|
Outcome Measures
| Title | Lung Volume Initiation |
|---|---|
| Description | Respiratory kinematic measure: lung volume initiation (LVI) Lung volume initiation is a measure of the volume of air in the lungs prior to a respiratory task. |
| Time Frame | 1 hour |
Outcome Measure Data
| Analysis Population Description |
|---|
| 25 healthy young volunteers participated in this study. The average age was 23 years and none had a history of respiratory or neurological disease. |
| Arm/Group Title | Healthy Adults Who Receive Capsaicin |
|---|---|
| Arm/Group Description | Single treatment consisting of healthy adults. Healthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times. |
| Measure Participants | 25 |
| Mean (Standard Deviation) [% Vital Capacity, relative to EEL] |
23.3
(5.7)
|
| Title | Peak Expiratory Airflow Rate |
|---|---|
| Description | Airflow measures: Peak expiratory airflow rate Peak expiratory flow rate is a measure of the velocity of air expelled from the respiratory apparatus during cough. Measured in liters/second. |
| Time Frame | 1 hour |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Healthy Adults Who Receive Capsaicin |
|---|---|
| Arm/Group Description | Single treatment consisting of healthy adults. Healthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times. |
| Measure Participants | 25 |
| PEFR - Voluntary Cough |
6.058
(.56)
|
| PEFR - Reflex Cough |
5.437
(.43)
|
| Title | Urge-to-cough |
|---|---|
| Description | Urge-to-cough: A measure of respiratory sensation that rates the perceived magnitude of the need to cough on a Borg scale (0=no urge-to-cough; 10=maximal urge-to-cough). |
| Time Frame | 1 hour |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Healthy Adults Who Receive Capsaicin |
|---|---|
| Arm/Group Description | Single treatment consisting of healthy adults. Healthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times. |
| Measure Participants | 25 |
| Median (Standard Error) [units on a scale] |
6
(.4)
|
Adverse Events
| Time Frame | All study participants were recruited during one month. | |
|---|---|---|
| Adverse Event Reporting Description | There were no adverse events associated with this protocol. | |
| Arm/Group Title | Healthy Adults Who Receive Capsaicin | |
| Arm/Group Description | Single treatment consisting of healthy adults. Healthy adults received capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. The participant received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants had a minute in between each presentation and water will be available at all times. | |
All Cause Mortality |
||
| Healthy Adults Who Receive Capsaicin | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Healthy Adults Who Receive Capsaicin | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Healthy Adults Who Receive Capsaicin | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Alexandra E. Brandimore, M.A. CCC/SLP |
|---|---|
| Organization | University of Florida |
| Phone | 352-273-3711 |
| aessman@ufl.edu |
- 32-2013